# K172855: Vitrea Advanced Visualization, Version 7.6

- Pathway: 510(k) (Special)
- Applicant: Vital Images, Inc.
- Decided: Oct 5, 2017 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150258: Vitrea, Version 7.0 Medical Image Processing Software, Vital Images, Inc. (2015) Summary page 4.

## Indications for use
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography.

Source page: https://510kreport.com/device/K172855
Methodology: https://510kreport.com/methodology